JPS6025260Y2 - endocardial pacing lead - Google Patents

Description

[Detailed description of the invention] The invention generally relates to a medical electrode carrier.
More specifically, endocardial basing leads (pacing
1ead).

Transvenous endocardial techniques are generally accepted as the preferred technique for long-term cardiac basing.

This approach is simple and less prone to the most troublesome problem of electrode misalignment, which interrupts or completely disables basing and/or sensing.

Electrode misalignment or adhesion imperfections typically range from 4.1% to as much as 30%.

The present invention overcomes the deficiencies in the prior art by providing a forward-extruding anchored endocardial basing lead.

The general purpose of the present invention is to provide a novel endocardial basing lead of the forward-extruding fixed type, which is highly flexible with a stress relief mechanism at the conductor-to-electrode interface of the lead. This is a combination of a basing lead and a retractable spiral coil.

An endocardial basing lead according to one embodiment of the present invention includes an electrode assembly and a conductor secured to the electrode assembly and having a connector at the other end, the electrode assembly being a retractable conductor rotatably mounted thereon. a helical coil, and a stylet wire inserted into the connector and basing lead couples to and rotates the helical coil, thereby anchoring the electrode to cardiac tissue.

One feature of the present invention is a forward-extruding anchored endocardial basing lead for use in unipolar ventricular basing intended for permanent use.

An active tissue plunging anchor member in the form of a platinum-iridium helical coil is plunged into the myocardium and compressed into the electrode assembly as the stylet wire of the wedge-shaped light end rotates. be done.

A ring-shaped endocardial electrode made of platinum-iridium surrounds the fixation coil.

In the contracted state, the helical coil is completely contained within the tip of the basing lead electrode assembly.

On the other hand, in a fully extended state, the tip of the helical coil projects two turns forward from the tip of the electrode.

The helical coil is used only for fixation purposes and is insulated from the ring-shaped electrode.

Another feature of the present invention is that the tip of the helical coil passes within a helical cavity in a silicone rubber guide seal plug located within the tip of the electrode assembly of the basing lead, and the guide seal The basting lead has a thin silicone rubber outer covering to prevent blood and tissue from entering the basing lead in either the expansion or contraction state.

Yet another feature of the invention is that the basing lead is first placed into the right ventricle using a stainless steel standard blunt tip stylet wire, then a plastic knob on the proximal end and a plastic knob on the distal end. A special stylet wire made of stainless steel, each with a wedge-shaped tip, is used as a flexible long screwdriver, and the wedge-shaped tip is inserted into a rectangular slot in a plastic sliding member attached to a helical coil. Rotate the stylet wire by engaging the tip,
The purpose is to expand and contract the wedge-shaped coil.

FIG. 1 is a plan view of the endocardial basing lead of the present invention, in which the endocardial basing lead 10 includes an electrode assembly 12 at the distal end of the lead 14 and a connector terminal 18 at the base of the lead 14. and a stylet 20 inserted into the endocardial basing lead 10.

FIG. 2 is a 2-2 cross-sectional view of the electrode assembly of FIG. 1.

The details of this will be explained below. The electrode assembly 12 includes a cylindrical tip electrode member 22 having a tapered portion 22a with a diameter 22b and a circumferential groove 22.
d and an end 22c of the structure having a circular bent end 22e.
It is equipped with

The inner diameter 22f is a silicone guide seal 36 which will be described in detail later.
A second inner diameter 22g receives a molded tapered sliding member 32, described in detail below, a third inner diameter 22h receives a stylet wire 20a of stylet 20, and a fourth inner diameter 22g receives a ring 36a of the stylet 20; Inner diameter 22i receives a three-turn conductor coil 26, and fifth inner diameter 22j receives a single-turn stress relief coil 30, which will be described in detail below.

A sleeve 24 having an outwardly projecting flange 24a fits over the inner diameter 22i of the electrode 22.

The flange 24a contacts the tip of the inner diameter 22i.

Inside the sleeve 124b is the stylet wire 20a
Accordingly, the outer diameter 24c is dimensioned to allow a gap to exist between the outer diameter 24c and the inner diameter 22i for arranging the three-winding conductor coil 26.

Coil 26 is held along sleeve 24 by mechanical pleats at 28a and 28b.

A single turn coil 30, which functions as a stress relief coil, slides over the coil 26 within the inner diameter 22j as shown.

This stress relief coil 30 extends from the rear portion 22j of the electrode 22 outwardly from the rear portion thereof.

A molded tapered sliding member 32 with a helical coil 34 is mounted within the electrode tip 22 for rotation about an axis.

The molded tapered sliding member 32 has a rear tapered portion 32a, a conical funnel portion 32b, and a square internal bore 32c for receiving the wedge-shaped light end 20b of the stylet wire 20.

The root portion 34a of the helical coil 34 is connected to the base body 32 at the closed end surface of the molded tapered sliding member.
d, and the tip of the coil 34 has a sharp tip 34.
It has b.

The helical coil 34 engages a helical lumen 36b of a guide seal 36, which is shown by way of example and is made of silicone rubber or other similar material.

The first part of the tip of the spiral coil is the guide seal 36
extends over most of the axial length of the guide seal 36, and reaches a sheath 36c made of the same material that covers the tip of the guide seal 36.

The outer ring 36a of the guide seal 36 fits into the inner diameter 22f of the electrode tip 22, thereby firmly fixing the guide seal 36 within the tip electrode 22.

After inserting the guide seal 36, helical coil 34, and molded tapered sliding member 32 into the tip electrode 22, the electrode tip 22k is bent over the guide seal 36 to form a circular bent end 22e. .

A urethane jacket 38 covers the tip electrode 22 and
It extends from the coil 26 at the rear end 22j to the outer circumferential groove 22d.

FIG. 3 is a diagram showing an example of the operation of the endocardial basing lead of the present invention, in which the molded tapered sliding member 32
A wedge-shaped tip 20b of the stylet wire is engaged within the wedge-shaped hole 32c.

When the stylet knob 20c is rotated, the molded tapered sliding member 3 rotates clockwise.
2 rotates and the helical coil 34 inside the guide seal 36
The base of the coil 34 rotates, and the sharp tip 34b of the coil 34
It penetrates through the tip outer covering 36c of the guide seal 36 made of silicone com shown in the figure and is fixed to the heart tissue in a clockwise direction.

End 36d of jacket 36c is turned over to provide a seal between tip electrode 12 and heart tissue.

After the stylet 20a has rotated twice and the sharp tip 34b of the distal end of the helical coil 34 is confirmed by fluoroscopy or the like to be secured to the heart tissue, the stylet 20 is withdrawn.

The tip electrode 22 can be placed in the apex of the right ventricle with the aid of fluoroscopy while the proximal end of the helical coil 34 is sufficiently retracted using a standard blunt tip stylet wire. .

The blunt stylet wire is then removed and a plastic stylet microadjuster is connected to the proximal end of the lead 10, followed by the introduction of the wedge-shaped stylet 20.

After confirming the electrode position using an electronic device, maintain some forward pressure by holding the lead 10 in place or using a ligature compression cuff to hold the lead 10 at the phlebotomy site. .

The wedge-shaped tip stylet knob 20c is used to advance and secure the helical coil 34 from the tip electrode 22.
is rotated clockwise in a stylet micro-adjustment device, and it is confirmed by fluoroscopy that the helical coil 34 protrudes two turns from the tip of the tip electrode 22.

The knob is rotated a complete 360°, but no more than 6 rotations are required.

To confirm the installation of the electrode 22, the stylet wire 2
Rotate 0a one more turn and half a turn to sense the increase in rotational resistance, then try pulling the lead under fluoroscopic diagnosis to sense the resistance, remove the stylet wire, and then take electrical measurements. Repeat to confirm normal operation.

Stress relief coil 30 provides flexibility of basing lead 14 at the junction of electrode assembly 12 .

Coil 30 distributes stress between the electrode and the basing lead over its length, preserving the integrity of the electrode assembly 12 within the basing lead.

Various equivalent modifications and modifications can be made within the scope of the gist of the present invention as described in detail above and as stated in the claims of the utility model registration.

Some embodiments of the present invention will be listed below.

(1) The fixing means is: a helical coil having a sharp tip at a first end and closed at a second end; and fixedly coupled to the second end of the helical coil. 2. The implantable lead of claim 1, further comprising a sliding member rotatably and slidably coupled to said electrode.

(2) The implantable lead according to (1) above, wherein the helical coil has a rotating and contracting helical lumen and includes a guide seal fixedly coupled to the electrode.

(3) The implantable lead according to (2) above, further comprising an outer sheath that is fixedly coupled to the tip of the guide seal.

(4) The implantable lead according to (2) above, wherein the sliding member has a proximal end having a funnel-shaped slot opening for easy insertion of a stylet.

(5) a. an electrode; b. a lead secured to the rear end of the electrode; and C. a stress relief coil extending over the lead across the electrode and the lead, the stress relief coil being connected to the stress relief coil. An endocardial basing lead characterized by providing continuity and distributed stress between the electrode and the lead over the length of the coil.

[Brief explanation of the drawing]

Fig. 1 is a plan view of the endocardial basing lead of the present invention, Fig. 2 is a sectional view taken along line 2-2 of Fig. 1 showing the state in which the helical coil is fully contracted, and Fig. 3 is a plan view of the endocardial basing lead of the present invention. FIG. 3 is an enlarged cross-sectional view of the electrode assembly showing the coil extended outward from the guide seal. 10... Endocardial basing lead, 12...
... Electrode assembly, 14 ... Lead, 16
...Connector, 18...Connector, 2
0...Stylet, 22...Tip electrode, 24...Sleeve, 30...Stress relief coil, 32...Sliding member , 34...
...Spiral coil, 36...Guide seal, 38...Urethane jacket.

Claims (1)

[Scope of utility model registration request] an electrical conductor having a distal end and a proximal end; an electrode coupled to the distal end of the electrical conductor; a fixation coupled to the electrode, capable of various extensions relative to the electrode, and fixing the electrode to body tissue for a long period of time; and a stress relief coil affixed to the electrode and the electrical conductor to disperse stress at the junction with the electrode and the electrical conductor over its entire length.